ELAN 4 GP586RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964776182), received between Mar 26, 2021 and Mar 26, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2021Break; Break

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GP586R - ELAN 4 SHANK F/SAW BLADE M TRANSVERS.95. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SHAFT OF THE DEVICE BROKE DURING SURGERY. THE USE WAS DISCONTINUED BECAUSE THERE WAS AN UNUSUALLY LARGE VIBRATION DURING THE SURGERY. WHEN THE CUSTOMER CHECKED THE SHAFT, IT WAS BROKEN AT THE ROOT. USED AT 20,000 RPM. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575567 ↗